Retaining device and method of using the same

ABSTRACT

A retaining device configured for retaining at least one medical device adjacent to a supporting surface. The retaining device includes a plate shaped holding portion defining a peripheral edge, a slot extending from the peripheral edge defining a loading channel, and communicating with an internal holding area. The internal holding area is dimensioned to accept the largest medical device the retaining device is configured to be used with. An attachment mechanism is connected to the holding portion to secure the retaining device to a supporting surface. A section of medical device may be inserted into and along the loading channel to enter the holding area and be retained within.

This application claims the benefit of U.S. Provisional PatentApplication No. 61/440,272, filed on Feb. 7, 2011, which is herebyincorporated by reference for all purposes as if fully set forth herein.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to retaining devices and, morespecifically, retaining devices for securing medical wires, catheters,guidewires, electrical lines, cables, tubing and other elongated membersduring medical procedures.

Discussion of the Related Art

Guidewires and catheters are used in a variety of different medicalprocedures such as, angiographic, endovascular, or surgical procedures.Guidewires arc typically used to position catheters in a body lumen, forexample arteries, veins or natural orifices within a mammal. The leadingend portion of the guidewire is typically introduced into the bodythrough an incision or natural orifice and then advanced to thetreatment area. A catheter can be threaded over the guidewire andadvanced over the guidewire to the treatment area. A single guidewirecan be used to deliver multiple catheters to the treatment area withinthe body lumen. This is normally accomplished by withdrawing andremoving the first catheter from the wire while leaving the leading edgeof the wire in place within the body lumen, and then threading a secondcatheter over the wire and advancing down to the treatment site.Multiple guidewires and catheters can be inserted into the body lumen atthe same time.

When the guidewire or a guidewire and catheter combination is placedwithin the body lumen, a loose trailing end portion extends out of thepatient from the entry point. This trailing end portion can be difficultto manage and requires special attention from the medical staff toensure it does not become contaminated, tangled or confused with otherwires in the procedural area.

Therefore, a device and method for retaining the trailing end ofguidewires and catheters is desired.

SUMMARY OF THE INVENTION

Accordingly, this invention is directed towards a retention device andmethod of using the same that substantially obviates one or more of theproblems due to limitations and disadvantages of the related art.

An advantage of the invention is to provide an apparatus to securelyretain a medical wire to a medical surface while providing ease ofloading and removal of the medical wire from the apparatus.

Yet another advantage of the invention is to provide a simple and securemechanism to attach an apparatus to a surface.

Still yet another advantage of the invention is to provide a retentiondevice that allows a guide and catheter exchanges without having toremove the guidewire or catheter from the retention device. Additionalfeatures and advantages of the invention will be set forth in thedescription which follows, and in part will be apparent from thedescription, or may be learned by practice of the invention. Theobjectives and other advantages of the invention will be realized andattained by the structure particularly pointed out in the writtendescription and claims hereof as well as the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the present invention, as embodied and broadly described, an aspectof the invention is directed towards a retaining device for securing amedical apparatus during a medical procedure. The retaining deviceincludes a base portion and a holding portion arranged at apredetermined angle from the base portion. The holding portion includesa peripheral edge including a slot extending from the peripheral edgedefining a loading channel and communicating with an internal holdingarea. The internal holding area is dimensioned to accept the medicalapparatus via the loading channel. An attachment mechanism is configuredto secure the base portion to a supporting surface, e.g., cloth, medicalgown, surgical drape, table or other substrate.

Another aspect of the invention is directed towards a method of using aretaining device to secure a medical apparatus to a predeterminedlocation. The method includes attaching a retaining device to asubstrate. The retaining device includes a loading channel and a holdingarea. Opening the loading channel of the retaining device and arranginga portion of the medical apparatus through the loading channel into aholding area of the retaining device.

Yet another embodiment of the invention is directed towards a medicalkit and instructions for use. The medical kit includes a retainingdevice according to any embodiment of the invention.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which arc included to provide furtherunderstanding of the invention, are incorporated in and constitute apart of this specification. They illustrate embodiments of the inventionand together with the description serve to explain the principles of theinvention.

In the drawings:

FIG. 1 is a perspective view of a retaining device according to anembodiment of the invention;

FIG. 2A is a perspective view of another embodiment of the invention;

FIG. 2B is a perspective view of another embodiment of the invention;

FIG. 3 is an alternate perspective view of the embodiment shown in FIG.2A;

FIG. 4 is a partial, perspective view of the sheet securing feature ofthe embodiment shown in FIG. 2A;

FIG. 5 is a partial, perspective view of the sheet securing feature ofthe embodiment shown in FIG. 2A;

FIG. 6 is a perspective bottom view of the sheet securing feature of theembodiment shown in FIG. 2A;

FIG. 7 is a perspective view of another embodiment of the invention; and

FIG. 8 is a side view of the embodiment shown in FIG. 6.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

An aspect of the invention is directed towards retaining devices and,more specifically, to retaining devices for securing a medical device,e.g., medical wires, catheters, guidewires, electrical lines, cables,tubing and other elongated members. The expression “medical device” isused herein as including all kinds of elongated members used duringmedical procedures, in particular catheters and guidewires.

In one embodiment, the retaining device for retaining at least onemedical device adjacent to a supporting surface includes a plate shapedholding portion defining a peripheral edge, a slot extending from theperipheral edge defining a loading channel, and communicating with aninternal holding area. The internal holding area is dimensioned toaccept the largest medical device configured to be used with theretaining device. An attachment mechanism is connected to the holdingportion to secure the retaining device to a supporting surface. Asection of medical device may be inserted into and along the loadingchannel to enter the holding area and be retained within.

In one embodiment, the holding portion is connected to a plate shapedbase portion with an adhesive coating for securing the retaining deviceto a supporting surface.

In one embodiment, the holding portion is flexible and a portion of theloading channel is dimensioned to be smaller than the smallest medicaldevice that is configured to be used with the retaining device. Aportion of the medical device enters through the channel into theinternal holding area. In this embodiment, this is accomplished byflexure of the holding portion thus permitting entry of a portion of themedical device into the holding area.

In one embodiment, the holding portion is connected to a plate shapedbase portion with an integral feature for securing the device to asupporting surface, e.g., a sheet or drape. The integral feature may bean adhesive, a square or rectangular tab cut from the base portion, orother mechanism. Another mechanism may include a slot dimensioned as acompressive fit as described with reference to U.S. Pat. No. 7,229,051,which is hereby incorporated by reference as if fully set forth herein.

In one embodiment, the retaining device is a one-piece structure and theholding portion is separated from the base portion by a bend or fold inthe device. The bend or fold may have an angle in range from about 5degrees to about 175 degrees, more preferably from about 30 degrees toabout 150 degrees and most preferably from about 75 degrees to about 115degrees.

In one embodiment, the holding portion has multiple slots within theholding area to provide aid in organization of multiple medical devices.Moreover, the shape of the holding portion may be any geometricconfiguration, e.g., a circle, square, triangle, tear drop, dual teardrop and/or combinations of the same.

In one embodiment, the holding portion is flexible and a portion of theloading channel is dimensioned to be smaller than the smallest medicaldevice that is configured to be used with the retaining device. Theholding portion along each edge of the loading channel is angled awayfrom the plane of the holding portion. Medical device entry into thechannel produces flexure of the angled channel and the holding portionthus permitting entry into the holding area.

In one embodiment, a retaining device for securing a medical apparatusduring a medical procedure includes a base portion and a holding portionarranged at a predetermined angle from the base portion. The holdingportion includes a peripheral edge including a slot extending from theperipheral edge defining a loading channel and communicating with aninternal holding area. The internal holding area is dimensioned toaccept the medical apparatus via the loading channel. An attachmentmechanism is configured to secure the base portion to a supportingsurface, e.g., cloth, medical gown, table or other substrate.

In one embodiment, a method of using a retaining device to secure amedical apparatus to a predetermined location includes attaching aretaining device to a substrate. The retaining device includes a loadingchannel and a holding area. Opening the loading channel of the retainingdevice and arranging a portion of the medical apparatus through theloading channel into a holding area of the retaining device.

In one embodiment, a medical kit includes a retaining device accordingto any embodiment of the invention and instructions for use. Theretaining device includes a base portion, a holding portion arranged ata predetermined angle from the base portion having a peripheral edgeincluding a slot extending from the peripheral edge defining a loadingchannel. The loading channel is in communication with an internalholding area. The internal holding area is dimensioned to accept themedical apparatus. An attachment mechanism is configured to secure thebase portion to a supporting surface. A portion of medical apparatus maybe inserted into and along the loading channel to enter the holding areaand be retained within

In addition to being easy to insert, remove, and securely retain medicaldevices, and secure the retaining device to various surfaces encounteredduring medical procedures, this invention allows the insertion andwithdrawal of catheters over retained guidewires during interventionalprocedures. This is important as removing the guidewire from theretaining device during a catheter removal or insertion adds additionalrisk to the guidewire or catheter falling from the procedural area andbecoming contaminated. It also allows for placement of the retainingdevice further from the catheter insertion point, thus adding moresupport where it is needed, near the end of the guidewire. The one-pieceflat plate construction with a fold or living hinge separating theholder and base portions has the advantage of economical manufacturing,a surface for printing measurement guides and instructions, andincreased utility as the user can bend the device to any angle desired.

Reference will now be made in detail to an embodiment of the presentinvention, example of which is illustrated in the accompanying drawings.

FIG. 1 shows a retaining device 10 according to an embodiment of theinvention. The retaining device 10 is configured to retain medical wiresor other surgical instruments. In the embodiments shown in the drawings,medical device retaining device 10 is generally a holding portion 11attached to a base portion 12. Base portion 12 is generally a plateshaped structure, of rectangular shape, for example, and forms themember of the medical device retaining device 10 will rest upon. Holdingportion 11 is generally placed at a right angle to base 12, however, itmay be configured at an angle within the range from about 0 to 180degrees during use or transport. For example, it may be advantageous tofold flat at about a 0 degree or 180 degree for product packaging orduring the procedure when device in not in use.

In one embodiment, the folding may be accomplished with a living hingebetween the base portion and the holding portion. The living hinge maybe produced by thinning or reducing the amount of material at thedesired bend point. Living hinges are most commonly used in plastics andcan be formed by molding, cutting, stamping, perforating and/or thinninga portion of the material at the fold, thereby creating a living hinge.In a preferred embodiment, the product would be manufactured and shippedflat and during use would be folded at the living hinge to the desiredorientation. During use the preferred range is from about 75 degrees toabout 115 degrees, and more preferably between about 85 degrees to about95 degrees. In a preferred embodiment, the retaining device 10 is aone-piece construction, where the holding portion and base portion areseparated by a bend and arc generally orthogonal to each other.

Holding portion 11 includes a plate shaped structure with a slotextending from the upper periphery and defining a loading channel 13,and communicating with an internal holding area 14. A portion of medicaldevice 15 may be inserted via a loading channel at the periphery of theholder portion 11 and into the holding area 14. Once in the holding area14 the medical device is substantially retained. In this embodiment, thewidth of the loading channel 13 is configured to accept the largest sizemedical device anticipated so that medical device insertion or removalhas no resistance. That is, the width is configured for a gauge wire ina range from about 0.015 inches to about 0.125 inches. This embodimentrelies on gravity and design of the holding portion to retain themedical device 15 in the holding area 14. The holding area 14 is sizedto accept the largest medical device and also allow any attachments tothe medical device to pass completely through the holding area. Forexample, a typical catheter will have a shaft diameter of 1.5millimeters (mm), however the trailing end of the catheter may have afluid connection fitting with a width of 10 mm and connected to thefitting may be a hemostasis valve with a width of 5 cm. Thus in thisexample the holding area would be dimensioned to allow the 5 cmhemostasis valve to pass completely through. In one embodiment, theholding area may have an area in the range from about 0.05 inches² toabout 28 inches², a preferred range from about 0.2 inches² to about 20inches², and a most preferred range from about 0.7 inches²to about 7inches².

In this embodiment, the base 12 contains an adhesive securing mechanism16 for connecting retaining device 10 to a supporting surface. Forexample, the adhesive is a pressure sensitive adhesive 16 covering asubstantial portion of the bottom of the base portion 12. Adhesive 16 iscovered with a protective, peel-off backing 17 until use. Other securingmechanisms as described herein may also be used.

FIG. 2A shows another embodiment of the invention. Referring to FIG. 2A,the retaining device 10 includes a holding portion 11 having at least aportion of the loading channel with a width of less than the smallestmedical device 15 anticipated to be used with the device. In oneembodiment, at least a portion of the loading channel may have a widthof about 0 inches or less to about 0.5 inches or greater. Thisembodiment adds more security to retain the medical device 15 in theholding arca 14. In order for the wire 15 to move through the channel 13a portion of the holding portion 11 must flex and allow the channel 13to open and accept the medical device 15. The flex of the holder portion11 is controlled by the cross-sectional area, height and modulus of theholder portion. By way of example, FIG. 3 shows flexing of a portion ofthe holding portion 11 to allow a medical device 15 to be inserted intoholding area 14. That is, one side of the holder portion 11 is flexedforward until the medical device 15 can drop in the holding area 14.Flexure of the holder portion 11 occurs either by pushing forward withthe medical device 15 when in contact with the holder portion 11 or bypushing manually with a finger. After loading, the holder portion 11returns to the shape shown in FIG. 2 and the medical device is retained.In one embodiment, the materials used in various features of the devicemay include a material such as thermoplastic, metal, alloy, plastic,polypropylene (PP), polyethylene (PE), polyethylene terephthalate(PETG), acrylonitrile butadiene styrene (ABS), nylon, polybutyleneterephthalate (PBT), styrene, polycarbonate, polytetrafluoroethylene(PTFE), fluorinated ethylene propylene (FEP), polyurethane, acetal,stainless steel, aluminum, steel, copper, brass, nitinol, andcombinations of the same.

The medical device 15 can be removed by manually flexing the holderportion 11 to open the loading channel 13. Flexure to open the loadingchannel 13 can occur by multiple or combination ways, for example, oneor both sides of the holder portion 11 could be twisted, or one or bothsides of the holder portion could flex laterally, or one or both sidesof the holder portion 11 could be flexed forward or backwards.

Also shown in FIG. 2A, the securing mechanism for retaining device 10 isconfigured to attach to a bed sheet, a medical drape or gown. In thisembodiment, base 12 includes an integral rectangular or square tab 20that has been cut from the base. The tab 20 has three sides and a bendon the remaining side connected to base 12 and angling up from the base.Below the tab 20 is an orifice 21 of corresponding shape, e.g.,rectangle, in the base approximately the same size as the tab 20. Anygeometrical shape of the tab may be utilized, e.g., triangle,semi-circle, multiple peaks, and the like. Moreover, the tab 20 mayinclude protrusions, e.g., barbs, to aid in securing to the bed sheet,drape or gown.

FIG. 4 shows an edge or folded edge of a sheet 22 placed over the base12 and under the tab 20. To secure the retaining device 10 to the sheet22, the tab is pushed down and through the orifice 21 and slightly belowthe plane of the base, wedging and locking the sheet 22 between the tab20 and orifice 21. FIGS. 5 and 6 show the sheet 22 in the lockedposition as viewed from above and below. This embodiment provides asimple, secure mechanism for securing the retaining device to a sheet,drape, or gown. To disengage the sheet 22, push the tab 20 back out theother direction from the bottom of the base 12. As shown in FIGS. 2-6,an advantage of this securing means is that it can be combined with theadhesive means 16 to provide increased utility for securing to manydifferent surfaces. In addition, other securing mechanisms may beutilized, for example, a securing device as described in U.S. Pat. No.1,389,304, which is hereby incorporated by reference as if fully setforth herein.

FIG. 2B, shows another embodiment of the invention. Referring to FIG.2B, the retaining device 10 is described with reference to FIG. 2Aexcept the internal holding area 14 has a different geometric pattern.In this embodiment, the internal holding area 14 includes two separatespaces. The loading channel 13 splits into two about halfway between theperipheral edge of the holder portion 11 and the bottom of the spaces,each communicating with holding area 14. The advantage of the embodimentis that it allows retention of multiple devices separately and alsoallows for a retention of a flexible medical device in a longitudinalfashion, as shown in FIG. 2B. Retention of a device in a longitudinalfashion is advantageous in situations where you want to restrict thelongitudinal movement of the device. As the device is placed into andout of the holding area 14 as shown a restriction of longitudinalmovement occurs. That is, a curvature of the device through the holes 14creates a friction at the edge of the holes thereby a longitudinalrestriction force may be utilized to prevent longitudinal movementassociated with the weight of the device. The device may still be movedlongitudinally, but more force than the weight of the device must beapplied. Alternatively, a “T” type channel 13 may be used rather thanthe curvature as shown in FIG. 2B.

FIG. 7 shows another embodiment of the invention. Referring to FIG. 7,the retaining device 10 is similar to the embodiment in FIG. 2, butincludes some additional features. The retaining device 10 may receivemultiple medical devices, e.g., guide wires secured within the holdingarca 14. The holding portion 10 includes two slots 26, e.g., V-shapedslots, near the bottom edge of the holding area 14. These slots areconfigured to hold and organize multiple wires 15 within the holdingarea 14. It is common during interventional procedures to have multiplecatheters or guidewires extending from the entry site and it isadvantageous to separate them to prevent tangling or to help identifythe wire(s).

A plurality of the holes 25 are configured to extend through the holderportion 10. These holes 25 provide multiple functions 1) a trailing endof a wire could be inserted through and looped, 2) the holes can act asmeasurement gauges for estimating medical device size, and 3) the holescan be used to alter the flexural strength of the holder portion.Another feature shown in FIGS. 7 and 8 is the angled tabs 23 and 24surrounding the channel 13 on the holder portion 11. Tab 23 on the rightside of the channel 13 is angled forward whereas tab 24 on the left sideof the channel is angled backward. The purpose of these tabs is toprovide easier insertion and removal of the medical device from theholding area and eliminate the need for manual flexing of the holderportion to remove or insert the medical device. Channel width 13 isstill smaller than the diameter of the smallest medical device to beused but when a medical device is pushed into the channel the tabs flexthemselves to open the channel 13 and at the same time flex the holderportion 11 to further open the channel and permit wire entry. Tab 23will flex forward and at the same time flex the right side of the holderportion 11 forward whereas tab 24 will flex backward and flex the leftside of the holder portion backward to open the channel and permit wireentry. This feature reduces the effort and force required to insert orwithdrawal a medical device and would be advantageous in situationswhere wires are frequently inserted and removed from the holding area.

EXAMPLES

Without intending to limit the scope of the invention, the followingexamples illustrate how various embodiments of invention may be madeand/or used.

Example 1

In this example, a retaining device similar to the device shown in FIG.2B was fabricated. A rectangular polypropylene sheet being about 1.25inches by 2 inches and about 0.03 thick was utilized. The corners ofthis sheet were radiused to about 0.25 inches with cutting shears. Twoholes being about 0.25 inches in diameter were punched in the holderportion using a leather punch. The center of each hole was spaced about0.50 inches from each other and extended from the top edge about 0.38inches and the side edge at about 0.38 inches. Each side of the loadingchannel was cut to include about a 0.25 inch radius shear cut extendingfrom the top edge and communicating with the bottom of each hole. Inaddition, a linear perforated line was punched across the part, parallelto and about 0.75 inches from the top edge using a perforated leatherpunch to form a living hinge.

A pressure sensitive adhesive with protective liner was cut to match thebase portion and adhered to the bottom side of the base. The pressuresensitive adhesive was 3M part no. 1567.

While the foregoing written description of the invention enables one ofordinary skill to make and use what is considered presently to be thebest mode thereof, those of ordinary skill will understand andappreciate the existence of variations, combinations, and equivalents ofthe specific embodiment, method, and examples herein. The inventionshould therefore not be limited by the above described embodiment,method, and examples, but by all embodiments and methods within thescope and spirit of the invention as claimed.

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the spirit or scope of the invention. Thus, it isintended that the present invention cover the modifications andvariations of this invention provided they come within the scope of theappended claims and their equivalents.

1-17. (canceled)
 18. A method of using a retaining device to secure amedical apparatus to a predetermined location, comprising the steps of:providing a retaining device; attaching a retaining device to asubstrate, wherein the retaining device comprises a base portion, aloading channel and a holding area; opening at least a portion of theloading channel of the retaining device; and arranging at least aportion of the medical apparatus through the loading channel into theholding area of the retaining device.
 19. The method of claim 18,wherein the medical apparatus comprises at least one of a medical wire,a guide wire, a catheter, an electrical line, a cable, and a tubing. 20.(canceled)
 21. The method of claim 19, further comprising the steps of:providing a second retaining device; attaching a second retaining deviceto the substrate, wherein the second retaining device comprises a secondbase portion, a second loading channel and a second holding area;opening at least a portion of the second loading channel of the secondretaining device; and arranging at least a portion of the medicalapparatus through the second loading channel into the second holdingarea of the second retaining device.
 22. The method of claim 18, whereinthe base portion comprises a first side, a second side, and a thirdside, and an internal portion comprising a flexible tab configured tomove from a first locking orientation to a second non-lockingorientation, wherein the attaching a retaining device to a substratestep comprises moving the flexible tab from non-locking orientation to alocking orientation in order to releasable couple the retaining deviceto the substrate.
 23. The method of claim 22, wherein the substratecomprises one of a cloth, medical gown, and surgical drape.
 24. A methodof using a retaining device to secure a medical apparatus, comprisingthe steps of: providing a retaining device comprising a base portion anda holding portion arranged at a predetermined angle from the baseportion, the holding portion having a peripheral edge including a slotextending from the peripheral edge defining a loading channel andcommunicating with an internal holding area, wherein the internalholding area is dimensioned to accept the medical apparatus via theloading channel; and arranging at least a portion of the medicalapparatus in the internal space through the loading channel.
 25. Themethod of claim 24, wherein the retaining device further comprises anattachment mechanism; and further comprising the steps of attaching theretaining device to a supporting surface with the attachment mechanism,wherein the supporting surface is selected from the group consisting ofa cloth, a medical gown, a surgical drape, and a table with theattachment mechanism.
 26. The method of claim 25, wherein the attachmentmechanism comprises an adhesive.
 27. The method of claim 25, wherein thepredetermined angle is a range from about 30 degrees to about 170degrees.
 28. The method of claim 27, wherein the predetermined angle isabout 90 degrees.
 29. The method of claim 24, wherein the internal spacecomprises a geometric configuration selected from the group consistingof a circle, a square, a triangle a tear drop, a dual tear shape andcombinations of the same.
 30. The method of claim 27, wherein the baseportion and a holding portion arranged at a predetermined angle from thebase portion with a living hinge.
 31. A method of using a retainingdevice to secure a medical apparatus, comprising the steps of: providinga retaining device comprising a base portion movably coupled to aholding portion with a living hinge, wherein the holding portioncomprises a loading channel and an internal space dimensioned to acceptthe medical apparatus though the loading channel, and arranging at leasta portion of the medical apparatus in the internal space through theloading channel.
 32. The method of claim 31, wherein the living hingeallows the holding portion to move from a first position to a secondposition different than the first position relative to the base portion.33. The method of claim 31, wherein the retaining device comprises amaterial selected from the group consisting of a thermoplastic, metal,alloy and combinations thereof.
 34. The method of claim 31, wherein theinternal space comprises at least one v-shaped slot.
 35. The method ofclaim 31, wherein the medical apparatus comprises a medical guidewire.36. The method of claim 31, wherein the retaining device furthercomprises an attachment mechanism.
 37. The method of claim 35, whereinthe attachment mechanism comprises an adhesive.
 38. The method of claim31, wherein the holding portion comprises a plurality of holes.